Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring
- Conditions
- Mitral Valve ProlapseVentricular Arrythmia
- Interventions
- Diagnostic Test: 14-day rhythm monitoring
- Registration Number
- NCT06378996
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
Mitral valve prolapse (MVP) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. This subgroup is referred to as AMVP (arrhythmic MVP) and was recently defined using the following criteria: (1) Presence of MVP), (2) Ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (PVC) burden on Holter) or complex (non-sustained ventricular tachycardia (nsVT), ventricular tachycardia (VT), or ventricular fibrillation (VF)), and (3) The absence of any other well-defined arrhythmic substrate.
Currently, diagnosis is often based on repeated 24-hour Holter monitoring. However, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days).
This pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with MVP as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Patients aged 18 years or older
- Mitral valve prolapse diagnosed on previous echocardiography or cardiac MRI
- New York Heart association classification ≥3
- Willing and able to provide signed written informed consent
- No contra-indication for long-term monitoring (known allergy to adhesives)
- Prior cardiac surgery, including previous mitral valve intervention
- Prior endovascular mitral valve repair (MitraClip)
- Previous catheter ablation of ventricular arrhythmias
- Patients not in sinus rhythm
- Patients on anti-arrhythmic drugs but betablockers
- Known alternative arrhythmic substrate, for example previous myocardial infarction
- Known allergy to adhesives
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 14 day monitoring 14-day rhythm monitoring -
- Primary Outcome Measures
Name Time Method Number of days with complex ventricular arrhythmia (nsVT, VT, or VF) 14 days Number of days with ≥ 1 nsVT, VT or VF episode
Number of days with high PVC-burden ≥5% 14 days Number of days with a PVC-burden ≥5%
Day-to-day variation in percentage PVC burden 14 days Day-to-day variation of the absolute number of PVC burden in percentage
Time to arrhythmic mitral valve prolapse detection 14 days The number of days to reach the detection of arrhythmic mitral valve prolapse, defined as a PVC burden ≥ 5%, nsVT, VT or VF
- Secondary Outcome Measures
Name Time Method Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI 14 days Correlation analysis of two continuous variables. The PVC burden will be calculated as the number of PVCs divided by the total number of heartbeats during the 14 days rhythm monitoring. Percentage of late gadolinium enhancement will be calculated as the ratio of the mass of myocardial tissue with late gadolinium enhancement over the total LV mass on cardiac MRI.
Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI 14 days Correlation analysis of two continuous variables. The mean number of nsVT episodes will be calculated as the average of nsVT episoden per day during the 14 days rhythm monitoring. Percentage of late gadolinium enhancement will be calculated as the ratio of the mass of myocardial tissue with late gadolinium enhancement over the total LV mass on cardiac MRI
Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography 14 days Correlation analysis of two continuous variables. The PVC burden will be calculated as the number of PVCs divided by the total number of heartbeats during the 14 days rhythm monitoring. Global longitudinal strain will be measured using conventional echocardiography on the 2-chamber, 3-chamber, and 4-chamber apical view.
Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography 14 days Correlation analysis of two continuous variables. Correlation analysis of two continuous variables. The mean number of nsVT episodes will be calculated as the average of nsVT episoden per day during the 14 days rhythm monitoring. Global longitudinal strain will be measured using conventional echocardiography on the 2-chamber, 3-chamber, and 4-chamber apical view.
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium